Device Recall Spirit Select Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CHG Hospital Beds Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    74560
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2332-2016
  • 사례 시작날짜
    2016-06-28
  • 사례 출판 날짜
    2016-08-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-06-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 원인
    Stryker medical is initiating a voluntary recall of the spirit select and spirit plus a-c powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury.
  • 조치
    The firm, Stryker Medical, issued an "URGENT MEDICAL DEVICE RECALL" letter dated 7/8/2016 by FedEx to its customers and included a revised preventive maintenance checklist. The letter described the product, problem and actions to be taken. The customers were instructed to: locate the units listed on the attached business reply form; remove these units from service, if not possible to remove units from service, place units in the height position according to instructions; file the revised preventative maintenance checklist; return the Business Reply Form to confirm receipt of the notification by fax (269)488-8691 or email productfieldaction@stryker.com. If customers have loaned or sold any of the beds listed in this letter, please forward a copy of the recall notice to the new users and advise us of their new location in the space provided on the business reply form. Your Stryker Field service Representative will contact your facility to add support brackets to your beds. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Online: www.fda.gov/medwatch/report.htm " Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch , P.O. Box 3002, Rockville, MD 20847-3002 " Fax: 1-800-FDA-0178 If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada
  • 제품 설명
    Spirit Select Bed, A-C Powered Hospital Bed
  • Manufacturer

Manufacturer

  • 제조사 주소
    CHG Hospital Beds Inc, 153 Towerline Place, London Canada
  • 제조사 모회사 (2017)
  • Source
    USFDA